FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
2545–2568 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 06, 2020
AI-Rad Companion Organs RT
K193562 · QKB
Siemens Medical Solutions USA, Inc.
Radiology · 319d
Cleared Nov 04, 2020
Arietta 65
K202422 · IYN
Hitachi Healthcare Americas
Radiology · 72d
Cleared Nov 04, 2020
MyHip Planner & Verifier
K200350 · LLZ
Medacta International S.A.
Radiology · 266d
Cleared Oct 30, 2020
HS30 Diagnostic Ultrasound System
K202556 · IYN
Samsung Medison Co., Ltd.
Radiology · 57d
Cleared Oct 30, 2020
WRDensity by Whiterabbit.ai
K202013 · QIH
Whiterabbit.Ai, Inc.
Radiology · 101d
Cleared Oct 30, 2020
T-Lite
K201988 · IYN
Sonoscanner
Radiology · 105d
Cleared Oct 30, 2020
AutoContour
K200323 · QKB
Radformation, Inc.
Radiology · 263d
Cleared Oct 29, 2020
CloudVue
K203058 · LLZ
International Medical Solutions, Inc.
Radiology · 21d
Cleared Oct 29, 2020
LSN
K201092 · JAK
Imaging Biometrics, LLC
Radiology · 189d
Cleared Oct 27, 2020
OrthoNext Platform System
K202519 · LLZ
Orthofix Srl
Radiology · 56d
Cleared Oct 27, 2020
Dental Computed Tomography X-Ray System, Green X
K201627 · OAS
VATECH Co., Ltd.
Radiology · 133d
Cleared Oct 26, 2020
1212FCA
K202722 · MQB
Rayence Co., Ltd.
Radiology · 39d
Cleared Oct 23, 2020
SIR-Spheres Microspheres Activity Calculator (SMAC)
K202392 · KPS
Sirtex Medical US Holdings, Inc.
Radiology · 63d
Cleared Oct 23, 2020
Planmed Clarity 2D and Clarity S
K192317 · MUE
Planmed OY
Radiology · 424d
Cleared Oct 22, 2020
EzOrtho
K202948 · LLZ
Ewoosoft Co., Ltd.
Radiology · 22d
Cleared Oct 22, 2020
Voluson E10
K201768 · IYN
Ge Healthcare
Radiology · 115d
Cleared Oct 21, 2020
OASIS MRI System
K202030 · LNH
Hitachi Healthcare Americas
Radiology · 91d
Cleared Oct 21, 2020
YSIO X.pree
K201670 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 124d
Cleared Oct 19, 2020
4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
K202374 · PGY
Shenzhen Beacon Display Technology...
Radiology · 61d
Cleared Oct 16, 2020
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio...
K202737 · IYN
Canon Medical Systems Corporation
Radiology · 28d
Cleared Oct 16, 2020
A View LCS
K201710 · LLZ
Coreline Soft Co., Ltd.
Radiology · 115d
Cleared Oct 15, 2020
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic...
K202683 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Oct 15, 2020
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
K202364 · IYN
Canon Medical Systems Corporation
Radiology · 57d
Cleared Oct 15, 2020
Cartesion Prime, PCD-1000A, V10.7
K202349 · KPS
Canon Medical Systems Corporation
Radiology · 58d